Pain, PostoperativeSPARCNCT03137732
Surgical Versus Anaesthetic Placement of Rectus Sheath Catheters
A study testing Rectus Sheath Catheter in people with Pain, Postoperative and Wound; Abdomen, run by Countess of Chester NHS Foundation Trust.
Trial summary
This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Wound; Abdomen, Incision
- What is being tested?
- Rectus Sheath Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Able to provide informed consent
- Undergoing elective, open colorectal surgery or emergency laparotomy via a midline incision extending above the umbilicus
- Weight of 50kg or over to standardise the analgesia given.
Who cannot join
- Weight of less than 50kg
- Patients unable to consent
- Age under 18 years
- Inability to insert RSC - local infection or severe coagulopathy
- Allergy to local anaesthetic
- Chronic pre-operative use of strong opioids or gabapentins and or chronic pain syndromes
Trial locations and contacts
No sites are listed yet.
Elizabeth G Kane, MBChB BSc MRCS contact
About this study
Official title: Surgical Placement Versus Anaesthetic Placement of Rectus Sheath Catheter for Pain Relief Following Major Abdominal Surgery (SPARC). A Single Centre Randomised Controlled Trial
This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery.
Read the detailed description
Background and study aims Pain management post laparotomy (abdominal surgery) can be difficult and in our trust we are increasingly using rectus sheath catheters (RSCs).This is achieved by placing catheters, done by either by the surgeon or anaesthetist into the potential space between the rectus muscle and the posterior rectus sheath. Two catheters are placed, one on either side of the mid-line wound. Local anaesthetic is then infused through the catheters for up to 3 days post-operatively. This provides analgesia to the central abdominal wall in the region of the T7-T11 dermatomes. It only provides analgesia for somatic pain, not visceral pain and hence needs to be used in addition to a multi-modal analgesic regime usually including a patient controlled analgesia device (PCA) containing either morphine or oxycodone. Advantages of a RSC infusion over an epidural include that it can be used in patients with coagulopathy or systemic infection and can be safely performed asleep. It is also less labour intensive to manage on the ward and does not carry the same risks of hypotension and excessive fluid administration that are associated with an epidural.
There is randomised controlled trial evidence that RSC infusions in addition to PCA provide superior analgesia when compared to PCA alone in surgery performed through a midline incision. There is also a randomised controlled trial in progress that is comparing analgesic quality of epidural infusions to RSC with PCA. In most published literature to date, RSC are inserted by the anaesthetist using ultrasound to aid placement. In our hospital, some RSC are inserted by anaesthetists although the majority are performed by surgeons at the end of an operation. This is because we believe that this technique is less time consuming and both insertion techniques result in equivalent analgesia.
The primary aim endpoint of this study is to determine any difference in insertion time for rectus sheath catheters between those inserted by surgeons and those inserted by anaesthetists. Observationally in our hospital, there is no difference in quality of analgesia provided by the two insertion techniques. However, surgical insertion of RSC causes less disruption of an operation as the patient already has their abdomen draped with sterilised skin as part of their surgical procedure. Also, surgical insertion of RSC with an open abdomen is potentially easier than ultrasound guided insertion by an anaesthetist before an operation.
Who can participate? Any adults undergoing emergency or elective laparotomy (major abdominal surgery.) What does the study involve? All participants will receive rectus sheath catheters but will be randomly allocated to each group. Following the surgery, participants will have to answer questions about their pain on 3 consecutive days.
What are the possible benefits and risks of participating? There are no specific benefits to patients and the risks are the same if they were in the trial or not as it is routine in our hospital to use rectus sheath catheters as a means of analgesia post laparotomy. These risks include bleeding, dislodgement of catheter and failure of catheter and are low risk.
Where is the study run from? This a single centre study at the Countess of Chester Hospital in the United Kingdom.
When is study starting and how long is it expected to run for? We anticipate recruiting patient from June 2017 for 6 months. How long will the trial be recruiting participants for? No funding is required as all data collection will be carried out by doctors working in the departments but the study is being supported and supervised by the Hospital's Research and Development department.
- Conditions
- Pain, Postoperative, Wound; Abdomen, Incision
- Being tested
- Rectus Sheath Catheter
- Medical subject headings
- Pain, Postoperative, Abdominal Injuries, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Sheath CatheterDevice
Insertion of rectus sheath catheter via either method
| Study group | Role | What they receive |
|---|---|---|
| Surgeon-inserted | Active comparator | Rectus sheath catheter will be inserted under direct vision / palpation of the space at the end of the operation. Receives: Device: Rectus Sheath Catheter |
| Anaesthetist-inserted | Active comparator | Rectus sheath catheter will be inserted under ultrasound guidance by the anaethetist. Receives: Device: Rectus Sheath Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to insert rectus sheath catheters
This will be recorded in theatre on a stopwatch and recorded.
Measured: under 15 minutes
Secondary outcomes (6)
Pain scores
Patients will be asked to score their pain in recovery and on days 0,1,2,3 post operatively. This will be graded using a Numeric Pain Rating Scale.
Measured: 4 days
Peri-operative analgesic use
Analgesic use intra-operatively and post-operatively for 3 days. This will include strong opioids, paracetamol, NSAIDs, codeine, ketamine, IV lignocaine, tramadol, clonidine and PCA usage post-operatively.
Measured: 4 days
Catheter issues
This includes haemorrhage, dislodgement, blockage
Measured: 4 days
Duration of catheter use
Measured: 4 days
TIme to diet and mobilisation
Measured: likely 1-3 days
Time to discharge
Measured: approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Countess of Chester NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dale Vimalachandran, Countess of Chester NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137732
- Sponsor's protocol ID
- Surg 058/17
- Acronym
- SPARC
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Placement Versus Anaesthetic Placement of Rectus Sheath Catheter for Pain Relief Following Major Abdominal Surgery (SPARC). A Single Centre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03137732
- Acronym / sponsor ID
- SPARC / Surg 058/17
- Conditions
- Pain, Postoperative, Wound; Abdomen, Incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Countess of Chester NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single centred randomized controlled trial comparing surgeon versus anaesthetist inserted rectus sheath catheters for management of analgesia post major abdominal surgery.
Detailed description
Background and study aims Pain management post laparotomy (abdominal surgery) can be difficult and in our trust we are increasingly using rectus sheath catheters (RSCs).This is achieved by placing catheters, done by either by the surgeon or anaesthetist into the potential space between the rectus muscle and the posterior rectus sheath. Two catheters are placed, one on either side of the mid-line wound. Local anaesthetic is then infused through the catheters for up to 3 days post-operatively. This provides analgesia to the central abdominal wall in the region of the T7-T11 dermatomes. It only provides analgesia for somatic pain, not visceral pain and hence needs to be used in addition to a multi-modal analgesic regime usually including a patient controlled analgesia device (PCA) containing either morphine or oxycodone. Advantages of a RSC infusion over an epidural include that it can be used in patients with coagulopathy or systemic infection and can be safely performed asleep. It is also less labour intensive to manage on the ward and does not carry the same risks of hypotension and excessive fluid administration that are associated with an epidural.
There is randomised controlled trial evidence that RSC infusions in addition to PCA provide superior analgesia when compared to PCA alone in surgery performed through a midline incision. There is also a randomised controlled trial in progress that is comparing analgesic quality of epidural infusions to RSC with PCA. In most published literature to date, RSC are inserted by the anaesthetist using ultrasound to aid placement. In our hospital, some RSC are inserted by anaesthetists although the majority are performed by surgeons at the end of an operation. This is because we believe that this technique is less time consuming and both insertion techniques result in equivalent analgesia.
The primary aim endpoint of this study is to determine any difference in insertion time for rectus sheath catheters between those inserted by surgeons and those inserted by anaesthetists. Observationally in our hospital, there is no difference in quality of analgesia provided by the two insertion techniques. However, surgical insertion of RSC causes less disruption of an operation as the patient already has their abdomen draped with sterilised skin as part of their surgical procedure. Also, surgical insertion of RSC with an open abdomen is potentially easier than ultrasound guided insertion by an anaesthetist before an operation.
Who can participate? Any adults undergoing emergency or elective laparotomy (major abdominal surgery.) What does the study involve? All participants will receive rectus sheath catheters but will be randomly allocated to each group. Following the surgery, participants will have to answer questions about their pain on 3 consecutive days.
What are the possible benefits and risks of participating? There are no specific benefits to patients and the risks are the same if they were in the trial or not as it is routine in our hospital to use rectus sheath catheters as a means of analgesia post laparotomy. These risks include bleeding, dislodgement of catheter and failure of catheter and are low risk.
Where is the study run from? This a single centre study at the Countess of Chester Hospital in the United Kingdom.
When is study starting and how long is it expected to run for? We anticipate recruiting patient from June 2017 for 6 months. How long will the trial be recruiting participants for? No funding is required as all data collection will be carried out by doctors working in the departments but the study is being supported and supervised by the Hospital's Research and Development department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon-inserted | Active comparator | Device: Rectus Sheath CatheterRectus sheath catheter will be inserted under direct vision / palpation of the space at the end of the operation. |
| Anaesthetist-inserted | Active comparator | Device: Rectus Sheath CatheterRectus sheath catheter will be inserted under ultrasound guidance by the anaethetist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged over 18 years
- Able to provide informed consent
- Undergoing elective, open colorectal surgery or emergency laparotomy via a midline incision extending above the umbilicus
- Weight of 50kg or over to standardise the analgesia given.
Key exclusion criteria (6 listed)
- Weight of less than 50kg
- Patients unable to consent
- Age under 18 years
- Inability to insert RSC - local infection or severe coagulopathy
- Allergy to local anaesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus Sheath CatheterInsertion of rectus sheath catheter via either method | Device | Anaesthetist-inserted, Surgeon-inserted |
Primary outcome
Time taken to insert rectus sheath catheters
Time frame: under 15 minutes
This will be recorded in theatre on a stopwatch and recorded.
6 secondary outcomes
Pain scores
Time frame: 4 days
Peri-operative analgesic use
Time frame: 4 days
Catheter issues
Time frame: 4 days
Duration of catheter use
Time frame: 4 days
TIme to diet and mobilisation
Time frame: likely 1-3 days
Time to discharge
Time frame: approximately 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth G Kane, MBChB BSc MRCS contact
Questions about this trial
What is this clinical trial studying?
A study testing Rectus Sheath Catheter in people with Pain, Postoperative and Wound; Abdomen, run by Countess of Chester NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dale Vimalachandran, MBChB MD FRCS (01244 365000, dale.vimalachandran@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken to insert rectus sheath catheters (time frame: under 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.